RT Journal Article
T1 A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial).
A1 Argiles, Guillem
A1 Mulet, Nuria
A1 Valladares-Ayerbes, Manuel
A1 Vieitez, Jose M
A1 Gravalos, Cristina
A1 Garcia-Alfonso, Pilar
A1 Santos, Cristina
A1 Tobeña, Maria
A1 Garcia-Paredes, Beatriz
A1 Benavides, Manuel
A1 Cano, María T
A1 Loupakis, Fotios
A1 Rodriguez-Garrote, Mercedes
A1 Rivera, Fernando
A1 Goldberg, Richard M
A1 Cremolini, Chiara
A1 Bennouna, Jaafar
A1 Ciardiello, Fortunato
A1 Tabernero, Josep M
A1 Aranda, Enrique
K1 Colorectal cancer
K1 Drug administration schedule
K1 Metastasis
K1 Regorafenib
AB The purpose of this article is to evaluate the safety of two regorafenib dose-escalation approaches in refractory metastatic colorectal cancer (mCRC) patients. Patients with mCRC and progression during or within 3 months following their last standard chemotherapy regimen were randomised to receive the approved dose of regorafenib of 160 mg QD (arm A) or 120 mg QD (arm B) administered as 3 weeks of treatment followed by 1 week off, or 160 mg QD 1 week on/1 week off (arm C). The primary end-point was the percentage of patients with G3/G4 treatment-related adverse events (AEs) in each arm. There were 299 patients randomly assigned to arm A (n = 101), arm B (n = 99), or arm C (n = 99); 297 initiated treatments (arm A n = 100, arm B n = 98, arm C n = 99: population for safety analyses). G3/4 treatment-related AEs occurred in 60%, 55%, and 54% of patients in arms A, B, and C, respectively. The most common G3/4 AEs were hypertension (19, 12, and 20 patients), fatigue (20, 14, and 15 patients), hypokalemia (11, 7, and 10 patients), and hand-foot skin reaction (8, 7, and 3 patients). Median overall survival was 7.4 (IQR 4.0-13.7) months in arm A, 8.6 (IQR 3.8-13.4) in arm B, and 7.1 (IQR 4.4-12.4) in arm C. The alternative regorafenib dosing schedules were feasible and safe in patients with mCRC who had been previously treated with standard therapy. There was a higher numerical improvement on the most clinically relevant AEs in the intermittent dosing arm, particularly during the relevant first two cycles. 
PB Elsevier
YR 2022
FD 2022-09-30
LK http://hdl.handle.net/10668/22181
UL http://hdl.handle.net/10668/22181
LA en
NO Argilés G, Mulet N, Valladares-Ayerbes M, Viéitez JM, Grávalos C, García-Alfonso P, et al. A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial). Eur J Cancer. 2022 Dec;177:154-163
DS RISalud
RD Apr 12, 2025